The new regulation will be implemented on January 1, 2021. Following the release of CSAR, China will publish a series of supporting documents and administrative rules, which will further establish China’s cosmetic regulatory framework.

To ensure a smooth transition, a five-year grace period was granted for hair growth, hair removal, breast beauty, slimming and deodorant products, which were already registered.

The new regulation brings many changes, below are some of the highlights:

• unified filing system for domestic and imported non-special use cosmetics (now referred as general cosmetics)
• new cosmetic ingredient registration and management
• new rules on efficacy testing and claim substantiation
• safety risk assessment and exemption from mandatory animal testing

Updated product categories

Toothpastes are now considered general cosmetics and are regulated under CSAR. However, soaps remain outside of scope of CSAR, with the exception of soaps with special cosmetic efficacy.

Cosmetic products are referred to as general cosmetics and special use cosmetics. The latter include hair dyes, hair perms, whitening products, sunscreen products, anti-hair loss products and products with new efficacies. These are all subject to pre-market registration. On the other hand, general cosmetics include all other cosmetic products and only require filing.

New cosmetic ingredient management

Cosmetic ingredients are classified as ‘’new’’ and ‘’used’’ ingredients. New ingredients with high risk, such as preservatives, sunscreens, whitening agents, colorants, and hair dyes require registration and approval from the National Medical Products Administration (NMPA). Other new ingredients are subject to filing with NMPA.

Cosmetic efficacy claims

Cosmetic claims must be substantiated by sufficient scientific evidence, which will be made publicly available on the NMPA’s website.

Safety assessment and animal testing

General cosmetics will no longer be subject to mandatory animal testing, whether they are produced domestically or imported into China. Safety assessments will be accepted in place of animal testing. However, there are some exceptions, which will still require animal testing:

• products intended for use by children or infants
• products with new ingredients, which have been approved but are not yet listed in the IECIC

Additional requirement for imported cosmetics

Imported cosmetic products also need to submit certifications relating to manufacturing quality control of the overseas manufacturers as well as documents, that prove those products have been placed on the market in the country of origin. For products, which are specifically produced for China, the applicant must provide research and test data for Chinese consumers.

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Which cosmetic products have to be tested?

In China, all cosmetic products except domestic non-special use cosmetics have to undergo mandatory testing at the NMPA accredited laboratories, even if they have already been tested abroad. This includes imported and domestic special use cosmetics as well as imported non-special use cosmetics. In addition, the necessary testing is also applicable to new cosmetic ingredient registration. Domestic non-special use cosmetics can avoid animal testing by providing a safety assessment, which should prove the safety of the product.

Types of tests that are performed at NMPA labs

Currently, there are 33 testing institutions approved by NMPA. Cosmetic testing at these labs includes various tests, which can be grouped into the following categories:
– Microbiological tests
– Hygienic chemical tests
– Toxicological tests
– Human safety tests
– Sunscreen efficacy testing

There are different tests required for different categories of cosmetics. Special use cosmetics require additional tests, and therefore the testing lasts longer than testing of non-special use cosmetics.

Microbiological testing

All non-special use cosmetics and most special use cosmetics have to undergo microbiological testing, which includes Aerobic bacterial count, Fecal coliforms, Staphylococcus Aureus, Pseudomonas Aeruginosa and Molds and yeast count test. Special use cosmetics, such as hair dye, hair perming, depilating products and deodorants, can be exempted from microbiological testing.

Hygienic chemical testing

Hygienic chemical testing includes many tests but all cosmetics, special use and non-special use, have to be tested for mercury, lead, arsenic and cadmium. Other tests, such as methanol, formaldehyde, hydroquinone and phenol, pH, thioglycolic acid etc. are required only for specific categories of special use cosmetics.

Toxicological testing

Toxicological testing differs for special and non-special cosmetics as well as within each of these product groups. Hair care, skin care, nail care, hair perming products and perfumes have to undergo acute skin irritation test. Products, which can come into contact with the eyes, such as hair products, certain skin care products and eye make-up products, have to undergo acute eye irritation test. There is also the multiple skin irritation test, which has to be performed for skin care products, make-up products and all special use cosmetics except for hair dye, hair perming and depilating products.

Special use cosmetics also have to undergo skin sensitization testing. Many of them have to undergo additional tests, such as skin phototoxicity test, Salmonella Typhimurium/Reverse Mutation Assay/Gene Mutation test and In Vitro Mammalian Cells Chromosome Aberration Test.

Human safety tests and efficacy testing

Special use cosmetics are also subject to skin patch tests or human trial tests, depending on the type of cosmetic product. In addition, sunscreen products also have to undergo SPF, PFA and water resistance testing.

Which tests are performed on animals?

Most of the toxicological testing is performed on animals. These tests cannot be avoided except if your product is eligible for application as a domestic non-special use cosmetic product or if you sell your products through Crossborder e-commerce (CBEC). Your product can fall under domestic product if you send your products in bulk to China and do the last step of packing your products in China. The other way to avoid animal testing is selling your product through CBEC, where registration of cosmetics, including testing at the NMPA labs, is not required.

Alternative methods to animal testing

China has accepted six alternative testing methods to animal testing so far – one test for assessing phototoxicity, one for skin corrosion, one for eye irritation and three for skin sensitization. The latter four will come into effect in January 2020. Two more tests are under research – one for assessing eye irritation and another one for genotoxicity.

New regulation on animal testing?

Recently, the NMPA released a draft version of Administrative Measures for Filing of Non-special Use Cosmetics. The draft mentions the possibility of imported non-special use products (with the exception of children products) being exempted from mandatory animal testing, provided that the safety risk assessment results can confirm that the product is safe for use.

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1. Check if ingredients are allowed for use in China

Firstly, it is important to check if the ingredients can be found on any of the lists published in the Chinese cosmetics regulation. In order to assure your formula contains only the ingredients allowed for use in cosmetics in China, they have to be found on the Inventory of existing cosmetic ingredients (IECIC 2015). If the ingredient cannot be found, it means you have a new cosmetic ingredient, which has not been used in China before. This means that in order to use this new ingredient, you will have to undergo the time-consuming process of new ingredient registration. If the ingredient is found to be safe by the competent authority, you will get a certificate with 4-year validity. If no adverse effects are observed during this time, the ingredient will be added to the IECIC.

If your ingredients can be found on the list of existing cosmetic ingredients, you also have to check the following lists:

• List of prohibited substances
• List of restricted substances
• List of allowed preservatives
• List of allowed UV filters
• List of allowed colorants
• List of allowed hair dyes

If your product contains a restricted ingredient, it is important to follow the restrictions provided in the Safety and Technical Standards for Cosmetics 2015.

2. Check the ingredient nomenclature

Cosmetic ingredients in the formula and on the label of the products that are sold in China have to be listed according to their Chinese INCI names. Therefore, it is important to make sure that you are using the correct nomenclature by checking the Catalogue of Standard Chinese Name of International Cosmetic Ingredients (INCI Chinese version).

It is possible that there is no INCI name for your ingredient. In this case, you can adopt its chemical name, botanical name or the name written in the Chinese Pharmacopoeia.

3. Check if the mixtures are written correctly

Like in the EU, in China, it is also important to write the whole composition of the mixture used in the formulation. If you have a raw material that is composed of different substances, you have to list all of them by their Chinese INCI name and also provide the percent of each ingredient in this mixture, as well as the percent of this raw material (mixture) in the finished cosmetic product.

4. Choose the appropriate ingredient function

According to the Chinese cosmetics regulation, there are only 69 cosmetic ingredient functions, which are allowed to be listed in the formula. It is important to choose only among those 69 functions and to choose the most appropriate one for your ingredient. The competent authority will check if the selected function corresponds to the ingredient. In case you have a mixture, the function should be applied to the mixture and not the individual substances.

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